Experimentation in Exchange for Freedom? Dan’s Law

Please take a few moments to read the article, When Drug Trials Go Terribly Wrong by Christopher Lane. I have posted several excerpts. Then, I ask you to please take some time to write to your federal legislator via fax or online to ask them to introduce a bill like Minnesota’s newly-passed Dan’s Law, to protect patients from being forced into clinical trials for experimentation that could lead to death.

Dan Markingson killed in a clinical trial he was forcibly enrolled in at University of Minnesota

Her son was encouraged to participate in a clinical trial at the University of Minnesota and other campuses comparing Seroquel, Risperdal, and Zyprexa for schizophrenia, schizoaffective disorder, and schizophreniform disorder, a loosely defined diagnosis for people suffering from “mood disorders with psychotic features.” The trial was sponsored by AstraZeneca, maker of Seroquel, which put the researchers and university in an obvious conflict of interest. Dan was given 800 mg of the drug.

Over 70% of patients in the trial dropped out. But Dan was strongly dissuaded from doing so and remained in it for five months. He’d been given a directive warning that if he failed to continue in the trial, he would be put in a regional treatment center. His mother did not know about the directive until it was too late.

The Pioneer Press reports: Ms. Weiss “thought that her son, Dan, wasn’t getting better during his six months in the study. [She] sent five letters and made numerous calls to the researchers, complaining that her son … didn’t have the wherewithal to consent to the study and requesting that he be withdrawn.”

But the university “disregarded her letters and calls,” the report continues. “She later filed a lawsuit, accusing Markingson’s psychiatrist and the study’s director, Dr. Stephen Olson, of coercing him to sign up. The lawsuit claimed the university kept Markingson enrolled to preserve its research and to keep payments coming for his participation.

“Do we have to wait until he kills himself or someone else,” she asked three weeks before the suicide, “before anyone does anything?”

…to convey the odds facing Ms. Weiss, in St. Petersburg, Florida, documents are soon to be released indicating that AstraZeneca, maker of Seroquel, was instructing its own drug reps to promote the drug as causing “less suicidal ideation than Risperdal or Zyprexa.” “Less suicide ideation” is not exactly a safety-standard that a reputable drug maker should be asking its staff to repeat.

But the rest of Ms. Weiss’s letter did contain some good news. Her struggle to get the university to admit responsibility for her son’s death, though turned down by one court, got the attention of lawmakers in St. Paul who wanted, with Mary, to make sure that participants in drugs trials in future could withdraw from them with less difficulty if, as Dan did, they began manifesting symptoms before the trial was scheduled to end.

“After four years’ effort,” Mary wrote me, “a bill in Minnesota has passed, effective August 1 this year, prohibiting anyone on a stay of civil commitment from entering a psychiatric clinical study.” Additional wording has strengthed the legislation, ensuring that the principal investigator in the study cannot also be the enrollee’s attending physician. “Next,” she continues, “I want to work to make people understand the danger of what the pharmaceutical companies are attempting to do—indeed are doing—to infiltrate our lives with drugs for whatever may ail us on a particular Tuesday morning.”

The new legislation is called “Dan’s Law,” in honor of Mary’s son, and though it currently contains a small loophole allowing doctors to petition the courts against the ruling, various state representatives as working hard to close that exception and make the legislation watertight.

I join countless colleagues, legislators, and state representatives in saluting Mary Weiss for her tireless advocacy for greater patient safety in drug trials. No one should be obliged to complete a clinical trial when they are manifesting acute side effects. The principal imperative in medicine must always be “Do no harm.”

It’s unconscionable that the doctors in charge of the clinical trial ignored this imperative and dissuaded Dan from withdrawing. The new law in Minnesota hopefully will make sure the same thing never happens again.